Ascension St John Urgent Care Claremore

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/20/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #1, laboratory support, and manager physician practice operations during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with laboratory support, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director or designee for one of five Chemistry Core events reviewed from 2022 through 2023. Findings include: (1) A review of the second and third 2022; and first, second, and third 2023 Chemistry Core proficiency testing records identified the following for one of five events: (a) Second 2023 Event - The attestation statement had not been signed by the laboratory director or designee. (2) The findings were reviewed with laboratory support who stated on 02/20/2024 at 11:35 am, the attestation statement had not been signed by the laboratory director or designee. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with laboratory support and technical consultant #1, the laboratory failed to follow their written policy for verifying the stated values of control materials prior to implementation for six of nine lot numbers used during the review period of June 2023 through the current date. Findings include: (1) On 02/20/2024 at 10:45 am, laboratory support stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XP-300 analyzer; (b) Three levels of EIGHTCHECK-3WP X-TRA QC (Quality Control) materials were tested each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of the policy titled, "Complete Blood Count (CBC) on the Sysmex XP 300 Automated Hematology Analyzer" under section E titled "Starting a New Lot of Controls" stated, "Parallel test new controls by analyzing the three levels of controls a minimum of twice a day for 5 days prior to the expiration of the previous lot"; (3) A review of records for nine control lot numbers used from June 2023 through the current date identified the laboratory had not followed their policy for six of nine lot numbers as follows: (a) Lot #31650710, 31650711, and 31650712 used from 06/29/2023 through 09/20/2023 - The laboratory had tested the controls three times on 06/27/2023 and three times on 06/28/2023; (b) Lot #32490710, 32490711, and 32490712 used from 09/21/2023 through 12/13/2023 - The laboratory had tested the controls one time on 09/11/2023, two times on 09/12/2023, one time on 09/13 /2023, one time on 09/14/2023, one time on 09/15/2023, one time on 09/16/2023, one time on 09/17/2023, and one time on 09/18/2023. (4) The findings were reviewed with technical consultant #1 who stated 01/04/2024 at 1:30 pm, the laboratory did not follow their written policy. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with laboratory support and physician practice operations manager, the laboratory failed to perform function checks every six months as defined by the manufacturer for the i- STAT 1 analyzer during the review period of May 2022 through the current date. Findings include: (1) On 02/20/2024 at 10:30 am, laboratory support and physician practice operations manager stated laboratory performed sodium, potassium, chloride, ionized calcium, TCO2, BUN (blood urea nitrogen), and creatinine testing using the Chem8+ cartridge and the i-STAT 1 analyzer; (2) A review of the i-STAT 1 -- 2 of 4 -- Operator's manual stated in chapter 14-1 (quality control),"Ensure the thermal probe check is performed every 6 months on each handheld reader"; (3) A review of records from 05/01/2022 through the current date identified no evidence the thermal probe checks had been performed prior to 04/24/2023; (4) The findings were reviewed with laboratory support and physician practice operations manager who stated on 02/20 /2024 at 11:55 am, the thermal probe checks had not been performed every six months. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with laboratory support and physician practice operations manager, the laboratory failed to perform calibration verification procedures at least once every six months for the i-STAT 1 test system during the review period of May 2022 through the current date. Findings include: (1) On 02/20 /2024 at 10:30 am, laboratory support and physician practice operations manager stated laboratory performed sodium, potassium, chloride, ionized calcium, TCO2, BUN (blood urea nitrogen), and creatinine testing using the Chem8+ cartridge and the i-STAT 1 analyzer; (2) A review of records from 05/01/2022 through the current date identified no evidence the calibration verification procedures had been performed prior to 05/17/2023; (4) The records were reviewed with the laboratory support and physician practice operations manager who stated on 02/20/2024 at 11:55 am, the calibration verification procedures had not been performed every six months. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through -- 3 of 4 -- 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with laboratory support and physician practice operations manager, the laboratory failed to perform QC (quality control) as stated in the IQCP (Individualized Quality Control Plans) for i-STAT 1 test system for one of 20 months reviewed. Findings include: (1) On 02/20/2024 at 10:30 am, laboratory support and physician practice operations manager stated the following: (a) The laboratory performed sodium, potassium, chloride, ionized calcium, TCO2, BUN (blood urea nitrogen), and creatinine testing using the Chem8+ cartridge and the i- STAT 1 analyzer; (b) Two levels of QC (quality control) materials were tested monthly according to the IQCP (Individualized Quality Control Plan). (2) A review of QC records from May 2022 through the current date identified no documentation to prove QC had been performed as stated in the QCP (Quality Control Plan) between 06 /01/2022 and 08/01/2022; (3) The records were reviewed with laboratory support and physician practice operations manager who stated on 02/20/2024 at 01:00 pm, QC had not been performed as shown above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/26/2022. The findings were reviewed with technical consultant #1 and technical consultant #3 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #3, the laboratory failed to review and evaluate proficiency testing results for one of 11 events. Findings include: (1) On 04/26/2022, a review of 2021 and 2022 proficiency testing records revealed the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) 2021 Second Hematology Event (i) MCH (Mean Corpuscular Hemoglobin) - three of five results exhibited a positive bias (aa) Sample HSY-06 - SDI of 2.0 (bb) Sample HSY- 08 - SDI of 3.3 (cc) Sample HSY-09 - SDI of 2.4 (2) There was no evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with technical consultant #3. Technical consultant #3 stated on 04/26/2022 at 12:15 pm the biases had not been addressed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #3, the laboratory failed to follow their policy for monitoring the effectiveness of their IQCP. Findings include: (1) On 04/26/2022 at 10:55 am, technical consultant #3 stated the following to the surveyor: (a) BUN, Chloride, Creatinine, Ionized Calcium, Potassium, Sodium, and TO2 (Chem 8+ cartridge) was performed using the iSTAT analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as approved on 06/30 /2020). The section titled, "Quality Assessment Monitoring" stated, "a. Monitoring of this plan will occur annually at minimum, and reevaluation will be considered whey any changes occur with the following: Testing personnel, environment, specimens, reagents, test system"; (3) The surveyor reviewed records for 2020 and 2021 and could not locate annual QA reviews since the IQCP had been approved on 06/30 /2020; (4) The surveyor reviewed the records with technical consultant #3 and asked if there was documentation of a QA review to evaluate the QCP annually. Technical consultant #3 stated to the surveyor on 04/26/2022 at 12:25 pm a QA review had not been documented as performed annually as stated in the policy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/17/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #1 and the laboratory coordinator at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory coordinator, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) During the survey, the surveyor reviewed personnel records for competency assessments performed during 2018 and to date in 2019. There was no evidence competencies had been performed for technical consultant #1, technical consultant #2, and technical consultant #3, based on their job responsibilities; (2) The surveyor asked the laboratory coordinator if a written policy to evaluate the technical consultants based on job responsibilities was available and if competencies had been performed during the review period. The laboratory coordinator stated a policy to evaluate the clinical consultant and technical consultant based on job responsibilities had not been written; and competencies had not been performed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory coordinator, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) At the beginning of the survey, the laboratory coordinator stated to the surveyor CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's weekly maintenance requirements as stated on the manufacturer's maintenance logs: (a) Clean SRV Tray (3) The surveyor then reviewed maintenance records from January 2018 through the day of the survey. There was no evidence the weekly maintenance had been performed: (a) Between 02 /13/19 and 03/06/18 (b) Between 03/19/18 and 04/03/18 (4) The surveyor reviewed the records with the laboratory coordinator, who stated the weekly maintenance had not been documented as performed as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with technical consultant #1, radiology team lead, and lab coordinator at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the radiology team lead and lab coordinator, the laboratory failed to ensure an analyzer was stored as required by the manufacturer. Findings include: (1) At the beginning of the survey, the radiology team lead and lab coordinator stated to the surveyors CBC (Complete Blood Count) testing was performed on the Sysmex XP 300 analyzer; (2) Later during the survey, surveyor #2 reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the relative humidity be maintained within the range of 30-85%; (3) Surveyor #2 reviewed laboratory humidity records from January 2016 through December 2017 which verified the humidity readings were less than 30% for 11 of 24 months as follows: (a) January 2016 - 26 of 31 humidity readings were documented as less than 30% (days 1,2,3,4,5,6,9,10,11,12,13,14,15,16,17,18,19,20,21,22,24,26,27,28,29,30); (b) February 2016 - 22 of 29 humidity readings was documented as less than 30% (days 1,3,4,5,7,8,9,10,11,12,13,14,15,16,17,18,22,24,25,26,27,29); (c) March 2016 - 12 of 31 humidity readings were documented as less than 30% (days Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 2,3,4,5,6,17,18,19,20,21,22,29); (d) April 2016 - 4 of 30 humidity readings were documented as less than 30% (days 2,3,8,9); (e) November 2016 - 5 of 30 humidity readings were documented as less than 30% (days 19,20,21,26,30); (f) December 2016 - 23 of 31 humidity readings was documented as less than 30% (days 1,2,3,7,8,9,10,11,12,13,14,15,16,19,20,21,22,23,27,28,29,30,31); (g) January 2017 - 25 of 31 humidity readings were documented as less than 30% (days 1,2,3,4,5,6,7,8,9,10,12,13,14,15,18,21,23,24,25,26,27,28,29,30,31); (h) February 2017 - 15 of 28 humidity readings was documented as less than 30% (days 1,2,3,4,5,9,10,13,14,15,16,17,25,26,27); (i) March 2017 - 12 of 31 humidity readings was documented as less than 30% (days 2,3,4,8,9,10,11,12,13,14,15,16); (j) November 2017 - 9 of 30 humidity readings was documented as less than 30% (days 1,7,9,20,21,22,25,26,27); (k) December 2017 - 20 of 31 humidity readings was documented as less than 30% (days 2,5,6,7,9,10,11,12,13,14,15,16,17,23,24,26,27,28,29,30); (4) The surveyors reviewed the records with the radiology team lead and lab coordinator who stated the humidity of the laboratory had been maintained below 30% as indicated above. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the radiology team lead and lab coordinator, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. It was identified for 3 of 6 events, the attestation statements had been signed approximately 2-3 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) First 2016 Hematology Event - The samples had been tested on 03/24/16 and the attestation statement had not been signed by the laboratory director until 06/14/16; (b) Second 2016 Hematology Event - The samples had been tested on 07/27/16 and the attestation statement had not been signed by the laboratory director until 10/11/16; (c) First 2017 Hematology Event - The samples had been tested on 03/23/17 and the attestation statement had not been signed by the laboratory director until 05/03/17. (2) The surveyors reviewed the findings with the radiology team lead and lab coordinator and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 2 of 2 --